Investigating The effect Of Self-treatment Maneuver At Home In the Recovery of Patients With Benign Paroxysmal Positional Vertigo-A Clinical Trial Study
The Efficacy Of Self-Treatment Maneuver At Home In The Recovery Of Patients With Benign Paroxysmal Positional Vertigo
Design
A Controlled Randomized Trial. A Parallel Group Design Of 86 Patients(Phase 3). SAS Software Version 9 Was Used For Randomization.
Settings and conduct
This randomized clinical trial (RCT) study was conducted on 86 patients with complaints of vertigo, who were diagnosed with benign positional vertigo (BPPV) by history and performing maneuvers. This study will be carried out in 1402 at the otolaryngology clinic of Amir Al Momenin in Rasht. The samples will be selected from among the people who referred to this department with the initial complaint of dizziness and imbalance and stated BPPV symptoms in the history taking. The rehabilitation treatment of patients with BPPV in the second group (intervention) is done using maneuver positioning training in self-treatment maneuvers at home in BPPV patients.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients Aged Between 18 To 90 Years In Whom BPPV Was Diagnosed Using The Dix-Hallpike Maneuver And Clinical Signs And Symptoms Exclusion Criteria: Patients whose cause of vertigo is other than BPPV.
Intervention groups
In the first group (control), only the Epley maneuver is performed to treat the patients. Rehabilitation treatment in the second group (intervention) is done by using the self-treatment positioning maneuver at home. In this study, Semont's modified self-treatment maneuver will be used. The patient does this 2 times on the right side and 2 times on the left side (2 times per day for 3 days).
Main outcome variables
Indicators of Benign Paroxysmal Vertigo according to DHI Scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220608055103N2
Registration date:2023-09-04, 1402/06/13
Registration timing:prospective
Last update:2023-09-04, 1402/06/13
Update count:0
Registration date
2023-09-04, 1402/06/13
Registrant information
Name
Shadman Nemati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3322 5242
Email address
drshadmannemati_ent@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2024-01-21, 1402/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating The effect Of Self-treatment Maneuver At Home In the Recovery of Patients With Benign Paroxysmal Positional Vertigo-A Clinical Trial Study
Public title
The Effect Of Self-Treatment Maneuver At Home In The Recovery Of Patients With Benign Paroxysmal Positional Vertigo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A Diagnosis Of BPPV With Dix-Hallpike Maneuver And Clinical Signs
No Previous Use Of Central Nervous System Depressants Or Stimulants In The Last 24 Hours
Exclusion criteria:
Other Causes Of Vertigo, Such As CPA Tumors, Anxiety Disorders, Confirmed Or Suspected Migraine
A Disease Or Condition For Which The Self-Treatment Maneuver, Or The Epley Maneuver Was Contraindicated, Such As Degenerative Disorders Of The Cervical Or Thoracic Spine, Detachment Of The Retina, Myocardial Infarction, Or Severe Obesity
Nystagmus That Indicates The Central Positional Nystagmus, Or Vestibular Migraine
Age
From 18 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
The Permuted Block Randomization Method Is Designed To Randomize Subjects Into Two Groups. It is used with a block size of 4 and an individual randomization unit. The Participants Were Randomly Assigned To Treatment Groups In Small "Blocks" Of Four Individual Participants At A Time Using SAS Software Version 9. According To The Type Of Intervention, There Is No Possibility Of Blinding. The Samples Will Be Selected From Among The People Who Referred To This Department With The Initial Complaint Of Dizziness And Imbalance And Who Stated BPPV Symptoms In The History Taking, By The Available Sampling Method By The Otolaryngologist. Interventions By The Specialist Otorhinolaryngology Will Be Performed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Guilan university of medical sciences
Street address
Amir Al Mo'menin Educational Remedial & Research Center, 17th Shahrivar
City
Rasht
Province
Guilan
Postal code
4139637459
Approval date
2023-04-19, 1402/01/30
Ethics committee reference number
IR.GUMS.REC.1402.003
Health conditions studied
1
Description of health condition studied
Benign Paroxysmal Positional Vertigo
ICD-10 code
H81.1
ICD-10 code description
Benign Paroxysmal Vertigo
Primary outcomes
1
Description
Indicators Of Benign Paroxysmal Positional Vertigo According to DHI Scale
Timepoint
The Evaluation Of Patients Will Be Done Before Treatment And 1 Month Post-Treatment.
Method of measurement
Dizziness Handicap Inventory Scale
Secondary outcomes
1
Description
The level of patient satisfaction with the effect and comfort of the treatment performed based on the scale (Visual Analogue Scale).
Timepoint
Before Treatment And One Month Post-Treatment
Method of measurement
Videonystagmography (VNG)
Intervention groups
1
Description
Intervention group: the rehabilitation treatment of BPPV patients in the intervention group is done by using self-treatment positioning maneuver maneuvers at home . In this research, modified semont maneuver will be used. Turn your head about 45 degrees away from the side affected by bppv. In this way, patients are advised to sit on the edge of the bed, put two pillows on both sides, and first put the hand under the affected ear, an angle of about 30 to 45 degrees is given upwards and turn the head 45 degrees away from the affected side. Lie down on the affected side quickly , while the ear is down and the eyes and chin are up. Wait for 20 seconds (or in case of dizziness until the episode of dizziness ends), then quickly returns to the sitting position. Then the patients should perform the same maneuver in reverse to the opposite side. They does this 2 times on the right side and 2 times on the left side (2 times per day for 3 days).
Category
Rehabilitation
2
Description
Control Group: In the control group, only the application maneuver is performed to treat the patients. The patient is placed from a sitting position to an open arched position. His head is turned 45 degrees to the right and remains in this position for 15 to 20 seconds. Then the head is turned to the left at an angle of 45 degrees and remains in this position for 10 to 20 seconds. Then the head is placed at a ninety degree angle so that the end part of the ear hits the ground. Then we return the patient to a sitting position. The opposite of this movement is done lying to the left.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Al Mo'menin Educational Remedial & Research Center
Full name of responsible person
Shadman Nemati
Street address
Amir Al Mo'menin Educational Remedial & Research Center, 17th Shahrivar
City
Rasht
Province
Guilan
Postal code
4139637459
Phone
+98 13 3323 8306
Email
drshadmannemati_ent@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Shadman Nemati
Street address
Amiralmomenin Hospital, 17th Shahrivar, Rasht, Gilan Province
City
Rasht
Province
Guilan
Postal code
4139637459
Phone
+98 13 3323 8307
Email
amiralmomenin@gums.ac.ir
Web page address
https://amir.gums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Shadman Nemati
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Amir Al Mo'menin Educational Remedial & Research Center, 17th Shahrivar, Rasht, Gilan Province
City
Rasht
Province
Guilan
Postal code
4139637459
Phone
+98 13 3323 8307
Email
drshadmannemati_ent@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Shadman Nemati
Position
Professor of Otology & Neurotology
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Amir Al-Momenin (AS) Educational and Medical Center, 17 Shahrivar St., Dr. Heshmat Square, Rasht
City
Rasht
Province
Guilan
Postal code
4139637459
Phone
+98 13 3322 5242
Fax
Email
drshadmannemati_ent@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Shadman Nemati
Position
Professor of Otology & Neurotology
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Amir Al-Momenin (AS) Educational and Medical Center, 17 Shahrivar St., Dr. Heshmat Square, Rasht
City
Rasht
Province
Guilan
Postal code
4139637459
Phone
+98 13 3322 5242
Fax
Email
drshadmannemati_ent@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
all collected deidentified IPD
When the data will become available and for how long
starting after publication
To whom data/document is available
people working in academic institutions
Under which criteria data/document could be used
The full profile and CV of the applicants will be reviewed by Dr. Shadman Nemati.
From where data/document is obtainable
Email: drshadmannemati_ent@yahoo.com
Address: Amir Al Mo'menin Educational Remedial & Research Center, 17th Shahrivar, Rasht, Gilan Province
What processes are involved for a request to access data/document
After reviewing the applicant's information, the applicant will be contacted by email.